510(k) Report

FDA applicant

Icl Scientific

Mchenry, IL48 decisions1976–19880 recalls

FDA records 48 decisions for Icl Scientific (Mchenry, IL) from 1976 to 1988: 48 510(k) clearances. Most are in product codes DEW (Igg, Antigen, Antiserum, Control) and JJW (Urinalysis Controls (Assayed And Unassayed)). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

How often FDA has decided Icl Scientific’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Icl Scientific since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Icl Scientific by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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